BIO|WOMEN Clinical Trial
Clinical Investigation on Differences in the Magnitude of CRT Response in WOmen Versus MEN
Study Design
- Prospective, multicenter, international study
- Evaluates gender differences in the magnitude of CRT response in a heart failure population
- 494 patients
Study Details
Study Objective
- BIO|WOMEN is a study designed to compare the CRT response rate in a heart failure population with an equal distribution of men and women
Primary Endpoint
- Magnitude of CRT response measured as a function of increase in left ventricular ejection fraction (LVEF) at 12 month follow up (FU)
Secondary Endpoints
- LVEDV and LVESV changes in both populations with CRT response
- Relationship between QRS duration (amount of asynchrony) and CRT response in both populations
Clinical Sites
- 27 sites in 8 countries (Austria, Belgium, Germany, Israel, Italy, Netherlands, Spain, UK)
Sample Size
- 494 patients
Main Inclusion Criteria
- Indication for a de novo implantation of a CRT device
Main Exclusion Criteria
- CRT device replacements or upgrades
- Permanent/persistent atrial fibrillation
- Cardiac surgery 3 months prior to the enrolment or planned within next 3 months
- Heart transplantation 6 months prior to the enrolment or expected within next 3 months
- Have a life expectancy of less than 12 months
- Subjects with irreversible brain damage from pre existing cerebral disease
- Subjects with acutely decompensated heart failure
- NYHA class IV heart failure
Devices
- BIOTRONIK CRT-Ds
Follow-Up
- Follow-up period 12 months
Study Duration
- June 2015 - December 2021
Reference no.
- NCT02344420
Principal Investigators
- Maria Jose Sancho-Tello, Hospital Universitario La Fe de Valencia